← Back to Search

Anti-infective agent

Clofazimine Inhalation for Nontuberculous Mycobacterial Infections (ICoN-1 Trial)

Phase 3
Recruiting
Research Sponsored by Mannkind Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be able to produce at least 3 mL of sputum or be willing to undergo an induction that produces at least 3 mL of sputum for mycobacteriology
Currently receiving a multi-drug regimen of GBT for pulmonary NTM infection in line with the 2020 ATS/ERS/ESCMID/IDSA guideline for the treatment of NTM pulmonary disease for at least 6 months prior to consenting in this study, with no changes in this regimen within 2 months of screening
Must not have
Prior therapy with clofazimine in the previous 4 months from date of screening
Prior therapy with amikacin by any route of administration in the previous 2 months from date of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of months 1,2,3,4,5, and 6
Awards & highlights

Summary

This trial will compare whether Clofazimine Inhalation Suspension is better than a placebo when added to standard therapy for a specific condition in terms of effectiveness and safety.

Who is the study for?
Adults aged 18-85 with lung disease caused by Mycobacterium Avium Complex (MAC), who are already on a multi-drug regimen for at least 6 months, can produce sputum samples, and have no recent use of certain drugs or conditions like active cancer. Women must not be pregnant and agree to contraception; men must also agree to contraception if they can father children.
What is being tested?
The trial is testing the effectiveness and safety of Clofazimine Inhalation Suspension compared to a placebo in patients with MAC lung disease. Participants will continue their current drug regimens alongside the trial medication or placebo.
What are the potential side effects?
Potential side effects may include hypersensitivity reactions due to clofazimine's ingredients, as well as any common side effects associated with inhalation therapies such as coughing or throat irritation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I can produce the required amount of sputum for the test.
Select...
I have been on a specific treatment for NTM lung infection for at least 6 months without changes.
Select...
I am between 18 and 85 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have not taken clofazimine in the last 4 months.
Select...
I have not taken amikacin in the last 2 months.
Select...
I have cystic fibrosis.
Select...
I have active tuberculosis.
Select...
I have a widespread MAC or MABSC infection.
Select...
My MAC infection is resistant to clofazimine.
Select...
My heart's electrical activity is irregular or too fast.
Select...
My family has a history of sudden or unexplained deaths related to heart issues.
Select...
I was in the ICU, with or without a breathing machine, in the last 3 months.
Select...
I have not taken bedaquiline in the last year.
Select...
My liver disease is in an advanced stage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~end of months 1,2,3,4,5, and 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and end of months 1,2,3,4,5, and 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
(Part A) Change in QoL-B RSS from baseline to end of Month 6 (Part A)
(Part A) Sputum culture conversion (i.e., 3 consecutive monthly sputum cultures negative for NTM) by the end of Month 6
Secondary outcome measures
(Part A) Change in 6-minute walk distance (6MWD) from baseline to the end of Month 6
(Part A) Change in participant identified Most Bothersome Symptom (MBS) from baseline to the end of Month 6
(Part A) Change in response to the Patient Global Impression of Severity (PGI-S) questionnaire from baseline to the end of Month 6
+2 more
Other outcome measures
(Part A) All-cause mortality
(Part A) Change in BMI from baseline to the end of Month 6
(Part A) Change in forced expiratory volume in 1 second (FEV1) from baseline to the end of Month 6
+41 more

Side effects data

From 2019 Phase 3 trial • 54 Patients • NCT03009396
13%
Weight increased
13%
Nausea
13%
Urinary tract infection
13%
Abdominal pain
13%
Chromaturia
13%
Weight decreased
13%
Dry mouth
13%
Arthralgia
6%
Decreased appetite
6%
Gastritis
6%
Frequent bowel movements
6%
Pruritis
6%
Lip dry
6%
Vomiting
6%
Siliva discolouration
6%
Dyspepsia
6%
Anal fistula
6%
Crohn's Disease
6%
Wheezing
6%
Porokeratosis
6%
Dental caries
6%
Pollakiuria
6%
Blood creatine phosphokinase abnormal
6%
Diarrhea
6%
White blood cell decreased
6%
Crohn's disease
6%
Pain of skin
6%
Dehydration
6%
Gingival discolouration
6%
Transaminases
6%
Fall
6%
Influenza
6%
Flatulence
6%
Electrocardiogram abnormal
6%
Upper respiratory tract infection
6%
Gastroenteritis norovirus
6%
Inflective scleritis
6%
Cough
6%
Insomnia
6%
Erythema
6%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
RHB-104 From RHB-104
RHB-104 From Placebo

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Clofazimine Inhalation SuspensionExperimental Treatment1 Intervention
MNKD-101 (Clofazimine Inhalation Suspension) is a micronized suspension with a concentration of 20 mg/mL. Study drug will be inhaled using the PARI breath-enhanced jet nebulizer system daily for 28 days in Cycle 1. Cycle 2 will commence after 56 days off treatment and resume daily for 28 days. Dose: 80 mg
Group II: PlaceboPlacebo Group1 Intervention
The placebo is comprised of isotonic saline (0.9% weight/volume sodium chloride). Study drug will be inhaled using the PARI breath-enhanced jet nebulizer system daily for 28 days in Cycle 1. Cycle 2 will commence after 56 days off treatment and resume daily for 28 days.

Find a Location

Who is running the clinical trial?

Mannkind CorporationLead Sponsor
59 Previous Clinical Trials
8,142 Total Patients Enrolled
Wassim Fares, MDStudy DirectorMannkind Corporation
1 Previous Clinical Trials
240 Total Patients Enrolled
~156 spots leftby Aug 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top